BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECOBALLOON DIL-XL

    MDR report key: 21573246 · Received March 11, 2025

    Report

    Report Number
    9611612-2025-00007
    Event Type
    Malfunction
    Date Received
    March 11, 2025
    Date of Event
    December 24, 2024
    Report Date
    March 11, 2025
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    GCJ
    PMA / PMN Number
    K090631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RN # 059-25_969 COMPLAINT TOOK PLACE IN JAPAN. BASED ON RISK ASSESSMENT AND CLINICAL ASSESSMENT THIS FILE IS CONSIDERED AS CLOSED. IN CASE NEW INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT TO THE AGENCY.

    Description of Event or Problem · 0

    IRN # 059-25_969 INCIDENT OCCURRED IN GREAT JAPAN: <EVENT/COMPLAINT> DURING EXPANDING, THE BALLOON WAS RUPTURED. THIS PRODUCT WAS USED IN ROBOTIC-ASSISTED LAPAROSCOPIC PARTIAL NEPHRECTOMY. THE USER DID NOT COUNT HOW MANY TIMES THE BALLOON WAS PUMPED TO INFLATE. <USE'S COMMENT> THE DOCTOR WHO REPORTED THE INCIDENT HAS EXPERIENCE WITH THIS PRODUCT. <JSS INVESTIGATION> WE CONFIRMED THE BALLOON IS RUPTURED AND SEPARATED. THE SEPARATED BALLOON MATERIAL IS SEPARATED INTO TWO PIECES. THE TROCAR APPEARS TO HAVE BEEN BROKEN TO CONFIRM BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    337454 ECOBALLOON DIL-XL BALLOON UNILATERAL EXTRA PERITONEAL DISTENTION SYSTEM_GCJ GCJ PAJUNK GMBH MEDIZINTECHNOLOGIE 1285-60-11 1510

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other